Steri-Oss, Inc.: FDA filings under this applicant name
FDA lists 46 510(k) clearances under the applicant name “Steri-Oss, Inc.” (first 1992, latest 1998), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 40 | 40 |
| EMA | Cement, Dental | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| EMM | Chisel, Osteotome, Surgical | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
Most recent Steri-Oss, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982400 | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT | EMA | 1998-09-23 | 75 |
| K980439 | REPLACE CYLINDRICAL IMPLANTS | DZE | 1998-03-16 | 40 |
| K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT | DZE | 1997-12-05 | 86 |
| K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT | DZE | 1997-12-05 | 86 |
| K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | DZE | 1997-11-26 | 78 |
| K972965 | STERI-OSS UNTIL IMPLANT CEMENT | EMA | 1997-11-07 | 88 |
| K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | NHA | 1997-07-03 | 176 |
| K964739 | STERI-OSS TIODIZED SCREW | DZE | 1997-03-31 | 125 |
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM | DZE | 1997-03-05 | 134 |
| K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | DZE | 1997-02-11 | 132 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Steri-Oss, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Steri-Oss, Inc.?
FDA lists 46 510(k) clearances under the applicant name “Steri-Oss, Inc.” (first 1992, latest 1998), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Steri-Oss, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Steri-Oss, Inc. is 88 days.
Which FDA product codes appear under Steri-Oss, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 40); EMA (Cement, Dental, 3); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Next steps
- See all 46 Steri-Oss, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Steri-Oss, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.